Ulcerative ColitisNCT00207688
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
An observational study of Ulcerative Colitis, run by Janssen Research & Development, LLC at 102 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Infliximab 5 mg/kg and Infliximab 10 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 102 sitesin 15 countries
- Study dates
- 31 Aug 2004to 9 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ulcerative colitis who have participated in infliximab clinical studies and must have received at least 1 dose of study medication to be eligible for participation in C0168T62.
Who may be able to join
- All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
- Patients must have received at least 1 dose of study agent to be eligible for participation in the study
Who cannot join
- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation
Trial locations and contacts
102 sites in 15 countries.
102 sites in 15 countries
United States44 sites
Study site
Anaheim, California
Study site
Asheville, North Carolina
Study site
Atlanta, Georgia
Study site
Beaver Falls, Pennsylvania
Study site
Boston, Massachusetts
Study site
Burlington, Vermont
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Egg Harbor, New Jersey
Study site
Great Neck, New York
Study site
Hartford, Connecticut
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Laurel, Maryland
Study site
Lexington, Kentucky
Study site
Lincoln, Nebraska
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Metairie, Louisiana
Study site
Milwaukee, Wisconsin
Study site
New Hyde Park, New York
Study site
New York, New York
Study site
Oakland, California
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Plymouth, Minnesota
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Tulsa, Oklahoma
Study site
Winston-Salem, North Carolina
Canada10 sites
Study site
Edmonton, Alberta
Study site
Edmonton
Study site
Halifax
Study site
Hamilton, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Québec, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
Australia8 sites
Study site
Bedford
Study site
Box Hill
Study site
Garran
Study site
Herston
Study site
Kogarah
Study site
Parkville
Study site
Perth
Study site
South Brisbane
United Kingdom7 sites
Study site
Cardiff
Study site
Dundee
Study site
Glasgow
Study site
Harrow
Study site
Liverpool
Study site
London
Study site
Manchester
France5 sites
Study site
Lille
Study site
Nancy
Study site
Paris
Study site
Strasbourg
Study site
Toulouse
Belgium4 sites
Study site
Antwerp
Study site
Brussels
Study site
Imeldalaan 9
Study site
Leuven
Denmark4 sites
Study site
Aalborg
Study site
Aarhus C
Study site
Copenhagen
Study site
Hvidovre
Israel4 sites
Study site
Jerusalem
Study site
Kfar Saba
Study site
Rehovot
Study site
Tel Aviv
Netherlands3 sites
Study site
Eindhoven
Study site
Nijmegen
Study site
Rotterdam
About this study
Official title: A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
Read the detailed description
This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected.
- Conditions
- Ulcerative Colitis
- Being tested
- Infliximab 5 mg/kg, Infliximab 10 mg/kg, Placebo
- Keywords
- Ulcerative Colitis, Infliximab, Remicade, Safety
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab 5 mg/kgDrug
Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
Infliximab 10 mg/kgDrug
Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
PlaceboDrug
Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab 5 mg/kg | This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. Receives: Drug: Infliximab 5 mg/kg | |
| Infliximab 10 mg/kg | This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. Receives: Drug: Infliximab 10 mg/kg | |
| Placebo | This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety
Long-term safety will be evaluated by assessment of serious infections,new malignancies (including colorectal cancer), new autoimmune diseases, death, delayed hypersensitivity (serum sickness-like) reactions, or dysplasia of the colon and other non-serious adverse events. Non-serious adverse events will be collected for participants continuing at the beginning of collection of non-serious adverse events.
Measured: 5 years
Secondary outcomes (4)
Number of patients with malignancies by malignancy type
Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies)
Measured: 5 years
Number of patients with serious infections by type of infection
Measured: 5 years
Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis
Measured: 5 years
Number of patients with hospitalizations for the treatment of ulcerative colitis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start31 Aug 2004
- Primary completion9 Sep 2015
- Study completion9 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biologics BV
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207688
- Sponsor's protocol ID
- CR004801
- Other IDs
- C0168T62
- Status last verified
- Jul 2018
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.
PubMed 19596014
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00207688
- Acronym / sponsor ID
- CR004801
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Infliximab, Remicade, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Biologics BV
- Study start
- 31 Aug 2004 (actual)
- Primary completion
- 9 Sep 2015 (actual)
- Study completion
- 9 Sep 2015 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
Detailed description
This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infliximab 5 mg/kg | – | Drug: Infliximab 5 mg/kgThis is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. |
| Infliximab 10 mg/kg | – | Drug: Infliximab 10 mg/kgThis is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. |
| Placebo | – | Drug: PlaceboThis is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ulcerative colitis who have participated in infliximab clinical studies and must have received at least 1 dose of study medication to be eligible for participation in C0168T62.
Key inclusion criteria (2 listed)
- All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
- Patients must have received at least 1 dose of study agent to be eligible for participation in the study
Key exclusion criteria (1 listed)
- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab 5 mg/kgPatients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed. | Drug | Infliximab 5 mg/kg |
| Infliximab 10 mg/kgPatients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed. | Drug | Infliximab 10 mg/kg |
| PlaceboPatients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed. | Drug | Placebo |
Primary outcome
Number of patients with adverse events as a measure of safety
Time frame: 5 years
Long-term safety will be evaluated by assessment of serious infections,new malignancies (including colorectal cancer), new autoimmune diseases, death, delayed hypersensitivity (serum sickness-like) reactions, or dysplasia of the colon and other non-serious adverse events. Non-serious adverse events will be collected for participants continuing at the beginning of collection of non-serious adverse events.
4 secondary outcomes
Number of patients with malignancies by malignancy type
Time frame: 5 years
Number of patients with serious infections by type of infection
Time frame: 5 years
Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis
Time frame: 5 years
Number of patients with hospitalizations for the treatment of ulcerative colitis
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 19596014Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.
- Multicenter International Study of the Long-term Safety of Infliximab (REMICADE®) in Ulcerative ColitisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
102 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Janssen Research & Development, LLC at 102 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Canada, Australia, United Kingdom, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events as a measure of safety (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.